决定异体 CAR T 细胞排斥与扩增的细胞和分子机制
Cellular and molecular mechanisms determining allogeneic CAR T cell rejection and expansion.
我们评估了11例接受单一批次cemacabtagene ansegedleucel(cema-cel)治疗的大B细胞淋巴瘤患者,cemacabtagene ansegedleucel是一种异体抗CD19 CAR T产品。
英文原题:Glofitamab: First Approval.
Glofitamab (Columvi) 是一种 CD20 CD3 T 细胞衔接双特异性单克隆抗体,由 Roche 开发,用于治疗 B 细胞非霍奇金淋巴瘤,包括弥漫性大 B 细胞淋巴瘤 (DLBCL)。
Glofitamab(Columvi)是一种由Roche开发的CD20 CD3 T细胞衔接双特异性单克隆抗体,用于治疗B细胞非霍奇金淋巴瘤,包括弥漫性大B细胞淋巴瘤(DLBCL)。Glofitamab于2023年3月25日在加拿大获得首次批准(附条件),用于治疗成人复发或难治性DLBCL(非特指型)、由滤泡性淋巴瘤转化而来的DLBCL或原发性纵隔B细胞淋巴瘤患者,这些患者已接受过两线或以上全身治疗,且不适合接受或无法接受CAR T细胞治疗,或既往已接受过CAR T细胞治疗。Glofitamab在欧盟和美国也正在接受复发或难治性DLBCL的监管审评,并于2023年4月获得积极意见,建议在欧盟授予附条件上市许可。Glofitamab作为单药治疗以及与其他药物联合治疗非霍奇金淋巴瘤的临床开发正在全球范围内继续进行。本文总结了Glofitamab开发过程中的里程碑事件,这些事件促成了其首次获批用于复发或难治性DLBCL。
Glofitamab (Columvi ) is a CD20 CD3 T-cell-engaging bispecific monoclonal antibody being developed by Roche for the treatment of B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma (DLBCL). Glofitamab received its first approval (with conditions) on 25 March 2023, in Canada, for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, DLBCL arising from follicular lymphoma, or primary mediastinal B-cell lymphoma, who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR T-cell therapy or have previously received CAR T-cell therapy. Glofitamab is also under regulatory review for relapsed or refractory DLBCL in the EU and USA and in April 2023 received a positive opinion recommending the granting of a conditional marketing authorization in the EU. Clinical development of glofitamab, as a monotherapy and in combination with other agents for the treatment of non-Hodgkin lymphomas, is continuing worldwide. This article summarizes the milestones in the development of glofitamab leading to this first approval for relapsed or refractory DLBCL.
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